This blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency, officially known as the California Institute for Regenerative Medicine(CIRM). David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.

Wednesday, October 24, 2012

One of the co-founders of Athersys,
Inc., of Cleveland, Ohio, is attempting to overturn reviewer
rejection of his company's application for an $8.3 million award from
the California stem cell agency to assist in a clinical trial for a therapy for stroke victims.

A document from Mays that CIRM released
said reviewers' objections could be addressed by “information that may
not have been adequately conveyed at the time or with new information
that has since become available.” The document laid out several
“recent” studies that it said supported its pitch for funding in
a phase two clinical trial.

CIRM's review summary also raised the
question of how much of the work would be done in California. The
stem cell agency is limited to funding research in California.

May's appeal said,

“We are conducting the phase 2
clinical study at many high volume clinical sites across the U.S.,
including in California. With respect to the process development work
intended to support scaled-up / optimized manufacturing for
subsequent phase 3 studies and commercialization, we plan to
complete key elements of this work in California, with collaborators
such as UC-Davis. We are in the process of building up our
California beachhead, and plan that several California-based
employees will manage the clinical study, as well as the process
development work. Ultimately, success in the phase 2 clinical study
and in the process development work would lead to the establishment
of a manufacturing plant in California to support later stage
development and commercialization in the western half of the U.S. and
Asia.”

The Athersys application came in CIRM's
first strategic partnership round. Two out of six applications were
approved by reviewers. The winners, whose identities are being
withheld until tomorrow by the stem cell agency, received scores of
88 and 73. The scores of the other applicants and their identities
were also withheld by the agency.

About Me

The California Stem Cell Report is the only nongovernmental website devoted solely to the $3 billion California stem cell agency. The report is published by David Jensen, who worked for 22 years for The Sacramento Bee in a variety of editing positions, including executive business editor and special projects editor. He was the primary editor on the 1992 Pulitzer Prize-winning series, "The Monkey Wars" by Deborah Blum, which dealt with opposition to research on primates. Jensen served as a press aide in the 1974 campaign and first administration of Gov. Jerry Brown. (Time served: two years and one week.) He writes from his sailboat on the west coast of Mexico with occasional visits to land. Jensen began writing about the stem cell agency in 2005, noting that it is an unprecedented effort that uniquely combines big science, big business, big academia, big politics, religion, ethics and morality as well as life and death. The California Stem Cell Report has been identified as one of the best stem cell sites on the Internet. Its readership includes the media (both mainstream and science), a wide range of academic/research institutions globally, the NIH and California policy makers.